RFID to enable ATMP Manufacturing, Cryogenic Supply Chain Scale-Up and Productivity Gains

"Manufacture of cell and gene therapies (also known as Advanced Therapy Medicinal Products or ATMPs) is highly labour intensive and technically complex requiring a three-phase process: Primary Manufacturing (production), Secondary Manufacturing (storage, packing and distribution) and Final Preparation (delivery and patient administration), which due to the specialist requirements are currently undertaken by different organisations, using different processes, in separate and often geographically remote locations. The manual processes and multiple handling required to produce ATMPs results in low throughput and high costs.

RFID technology is a well-established technology platform in high-volume sectors, such as the automotive industry and Fast Moving Consumer Goods, and is used to facilitate tracking and traceability of individual components, sub-systems and final product within and between sites. However, these systems cannot be simply transferred across to the ATMP industry due to the unique challenges associated with ATMP manufacture, including aspects of product viability, shelf life, batch sizes, cryogenic temperatures required for product storage and complex regulations to ensure patient safety.

This project will develop and demonstrate a full-scale, regulatory compliant, cryogenic RFID system which works across the three stages of ATMP manufacture. The final system will de-risk and overcome a number of critical barriers to enable full and seamless adoption into the ATMP industry."